drugset / Trial / NCT03992066
Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
This study will be conducted to assess the pharmacokinetics of vadadustat 600, 750, and 900 milligrams daily, and intravenous erythropoiesis-stimulating agent (darbepoetin alfa or epoetin alfa), in hemodialysis participants with anemia associated with chronic kidney disease.
Timeline
- Start
- 2019-05-28
- Primary completion
- 2020-05-05
- Completion
- 2020-07-15
Publications
- Navarro-Gonzales P, Chavan A, Wang D, Burke SK, Dykstra K. A randomized trial to evaluate the pharmacokinetics, pharmacodynamics, and safety of vadadustat in patients with anemia associated with chronic kidney disease receiving hemodialysis. BMC Nephrol. 2025 Aug 11;26(1):453. doi: 10.1186/s12882-025-04367-x.
- Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vadadustat | Small molecule | 600 mg | Oral |
| Subject | Vadadustat | Small molecule | 750 mg | Oral |
| Subject | Vadadustat | Small molecule | 900 mg | Oral |
| Background | Darbepoetin alfa | Protein / enzyme biologic | — | Intravenous |
| Background | epoetin alfa | Protein / enzyme biologic | — | Intravenous |